Director, Consumables Manufacturing (Medical Diagnostic Device)
Job Description
Job Description
About General Fluidics:
At General Fluidics, we are transforming global healthcare by making high-quality blood diagnostics radically more accessible. Our AxessTM point-of-care platform brings the analytical performance of the central lab to the bedside, enabling clinicians to make faster, more informed decisions while improving patient outcomes.
Our mission is bold: to revolutionize diagnostics by delivering the most comprehensive, highest quality, and lowest cost blood testing solution to point-of-care settings. We believe the future of healthcare must be faster, more flexible, and more equitable—and we’re building the tools to make that future real.
Position Summary
Reporting to the VP, Engineering, we are seeking an experienced and tactical Associate Director/Director, Manufacturing (Consumables) to support scale up and organization of our manufacturing function. You will play a critical role in developing our AxessTM diagnostic platform from early-stage development into production. This is a unique opportunity to take part in a manufacturing organization of a category-defining med tech company from day one.
You will be responsible for setting up and leading the prototype consumable manufacturing process. The ideal candidate is an execution-focused technical expert with experience in automation and establishing manufacturing process for complex diagnostic technologies.
Key Responsibilities
- Establish scalable infrastructure to support early production.
- Support manufacturing activities for the AxessTM system, focusing principally on consumables.
- Oversee production planning, inventory management, procurement, and materials flow to ensure efficient operations and on-time delivery.
- Drive continuous improvement across cost, quality, yield, and throughput.
- Collaborate cross-functionally with Engineering and Research teams to ensure successful design transfer of consumables.
- Recommend scalable, validated processes for assembling and testing consumables.
- Guide pilot manufacturing activities and support transition to commercial-scale production.
- Familiarity with all applicable standards, including FDA QSR, ISO 13485, cGMP, and other global regulatory requirements.
- Build strong partnerships with critical suppliers to ensure quality, cost, and delivery performance.
- Maintain supply agreements, technical documentation, and performance metrics.
- Implement continuous improvement methodologies to optimize operations.
Qualifications
- Bachelor’s degree in Engineering, Operations, or a related technical field; Master’s preferred.
- 8+ years of progressive experience in manufacturing operations, with at least 4 years in medical device or diagnostic product manufacturing.
- Experience with manufacturing operations for med device consumables.
- Familiarity with FDA regulations, ISO 13485, GMP, and international quality standards.
- Experience in managing facilities, vendors, and contract manufacturers.
Company DescriptionGeneral Fluidics, is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology and immunoassays from human and animal blood (https://www.generalfluidics.com). We are creating an entirely new category of blood testing technology that brings the quality and menu of the reference laboratory to the point of care. Our AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus.
Company Description
General Fluidics, is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology and immunoassays from human and animal blood (https://www.generalfluidics.com). We are creating an entirely new category of blood testing technology that brings the quality and menu of the reference laboratory to the point of care. Our AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus.